Devices, systems and methods for removal and replacement of a catheter for an implanted access port

ABSTRACT

A medical device is provided which comprises an implantable vascular access port including a fluid passage operable to introduce fluid to a host and/or remove fluid from the host, the fluid passage accessible through a fluid passage access opening and at least a portion of the fluid passage defined by a needle configured to penetrate cutaneous tissue of the host; and an implantable vascular access catheter connectable with the vascular access port; wherein the vascular access catheter and the vascular access port are connectable to each other within the vascular access port.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a continuation of U.S. Patent ApplicationSer. No. 14/975,638 filed Dec. 18, 2015, which claims the benefit of thefiling date of U.S. provisional patent application Ser. No. 62/093,769filed Dec. 18, 2014, the entire disclosure of which is incorporatedherein by reference.

FIELD

The present disclosure relates to medical devices, systems and methods,and more particularly to medical devices, systems and methods forremoval and replacement of an implanted catheter connected to animplanted access port, particularly an implanted vascular accesscatheter connected to an implanted vascular access port.

BACKGROUND

Medical patients, such as oncology patients, hemodialysis patients andhematology patients, may be subject to frequent fluid infusiontreatments (e.g. delivering fluids comprising pharmaceuticals, blood,nutrients, contrasting agents and other compositions) and/or fluidextraction treatments (e.g. removing fluid comprising blood as part ofphlebotomy). Frequent “needle sticks” and the duration of infusion timemay make receiving such treatments difficult and/or uncomfortable, andmay create scarring and added discomfort to the patient.

Vascular access ports may now be inserted beneath the cutaneous tissue(skin) of the patient to reduce discomfort and increase efficiencyassociated with such treatments. A vascular access port may include anaccess point, such as a septum, into which a needle may be inserted, ora needle residing in the vascular access port may be raised from underand through the cutaneous tissue.

An implanted vascular access (indwelling) catheter is ordinarilyconnected to an implanted vascular access port. The vascular accesscatheter may be inserted into a vein, such as a jugular vein, subclavianvein or the superior vena cava.

Vascular access catheters are known to be connected to the vascularaccess port by providing the vascular access port with a male (stem)fitting including a plurality of conical barbs which are designed toengage within the lumen inside of the vascular access catheter. In lightof such, once such a vascular access port and catheter are implanted,there is no non-surgical way to remove and replace the vascular accesscatheter without reopening the implantation (surgical) site.

Unfortunately, maintaining the patency of a vascular access catheter maybecome more difficult over time. In-growth and blood clotting may clogand inhibit fluid flow through the vascular access catheter, either byreducing fluid flow or completely preventing fluid flow. One method oftrying to maintain patency may include flushing the vascular accesscatheter with saline or other fluid agents, but such approaches may haveonly limited success and suffer from several disadvantages. Oncein-growth has begun, the efficacy of flushing alone may become limited.Moreover, material removed by the flushing may be deposited into thevasculature, and could be deposited elsewhere in the circulatory system.

SUMMARY

The present disclosure relates to medical devices, systems and methods,and more particularly to medical devices, systems and methods forremoval and replacement of an implanted catheter connected to animplanted access port, particularly an implanted vascular catheterconnected to an implanted vascular access port.

In certain embodiments, a medical device may comprise an implantablevascular access port including a fluid passage operable to introducefluid to a host and/or remove fluid from the host, the fluid passageaccessible through a fluid passage access opening and at least a portionof the fluid passage defined by a needle configured to penetratecutaneous tissue of the host, and an implantable vascular accesscatheter connectable with the vascular access port, wherein the vascularaccess catheter and the vascular access port are connectable to eachother within the vascular access port.

As set forth by the present disclosure, by establishing a connectionbetween the vascular access catheter and the vascular access port withinthe vascular access port (as opposed to a vascular access catheter beingconnected to the vascular access port by providing the vascular accessport with a male stem fitting), the vascular access catheter may beremoved from the host and replaced without having to open a surgicalsight.

In certain embodiments, the vascular access catheter is insertable intothe fluid passage of the vascular access port through the fluid passageaccess opening and removable from the fluid passage of the vascularaccess port through the fluid passage access opening.

In certain embodiments, the portion of the fluid passage defined by theneedle is defined by a lumen of the needle, and the vascular accesscatheter is insertable into the lumen of the needle through the fluidpassage access opening and removable from the lumen of the needlethrough the fluid passage access opening.

In certain embodiments, the vascular access catheter and the vascularaccess port are connectable to each other within the vascular accessport by a mechanical connection.

In certain embodiments, the mechanical connection comprises at least oneof a friction fit connection and a positive mechanical engagementconnection.

In certain embodiments, the positive mechanical engagement connectioncomprises an overlapping connection formed by a proximal end portion ofthe vascular access catheter and a portion of the vascular access port.

In certain embodiments, the overlapping connection is formed by a flangeof the vascular access catheter overlapping with a shoulder of thevascular access port.

In certain embodiments, the friction fit connection comprises apress-fit connection formed by a proximal end portion of the vascularaccess catheter and a portion of the vascular access port.

In certain embodiments, the vascular access port includes a catheteregress opening, and the press-fit connection is formed by at least oneresilient deformable retention element of the vascular access catheterdeforming against a sidewall of the catheter egress opening when locatedin the catheter egress opening of the vascular access port.

In certain embodiments, the vascular access catheter comprises a tubularbody and a proximal end portion which are insertable into the fluidpassage of the vascular access port through the fluid passage accessopening and, when the tubular body and the proximal end portion of thevascular access catheter are inserted into the fluid passage of thevascular access port, the tubular body of the vascular access catheterextends from a catheter egress opening of the vascular access port whilea mechanical interference inhibits the proximal end portion of thevascular access catheter from passing through the vascular access portand being removed from the vascular access port through the catheteregress opening.

In certain embodiments, the fluid passage of the vascular access porthas a fluid passage diameter and the catheter egress opening of thevascular access port has a catheter egress opening diameter, wherein theproximal end portion of the vascular access catheter has a diametersmaller than the fluid passage diameter and larger than the catheteregress opening diameter, and wherein the mechanical interference whichinhibits the proximal end portion of the vascular access catheter frompassing through the vascular access port and being removed from thevascular access port through the catheter egress opening is formed bythe proximal end portion of the vascular access catheter have a diameterlarger than the catheter egress opening diameter.

In certain embodiments, the vascular access port includes a housing, andthe connection within the vascular access port is formed with thehousing.

In certain embodiments, the housing includes a catheter egress opening,and the connection within the vascular access port is formed with aportion of the housing defining at least a portion of the catheteregress opening.

In certain embodiments, the housing includes a stem extending outwardfrom a wall of the housing, and the catheter access opening is providedin the stem.

In certain embodiments, the housing includes a catheter retention memberconnected to a wall of the housing, and the catheter access opening isprovided in the catheter retention member.

In certain embodiments, the catheter retention member is disconnectablefrom the wall of the housing, and comprises at least one screw threadwhich threadably engages with at least one screw thread of the housing.

In certain embodiments, the vascular access catheter is connectable withthe vascular access port within the fluid passage of the vascular accessport.

In certain embodiments, the present disclosure provides a catheterinsertion tool configured to insert the vascular access catheter intothe vascular access port through the fluid passage access opening andthe fluid passage of the vascular access port.

In certain embodiments, the catheter insertion tool is furtherconfigured to engage a mechanical connection between the vascular accesscatheter and the vascular access port, and the catheter insertion toolis configured to operate with a guidewire.

In certain embodiments, the present disclosure provides a catheterremoval tool configured to remove the vascular access catheter from thevascular access port through the fluid passage and the fluid passageaccess opening of the vascular access port.

In certain embodiments, the catheter removal tool is further configuredto disengage a mechanical connection between the vascular accesscatheter and the vascular access port, and the catheter removal tool isconfigured to operate with a guidewire.

In certain embodiments, the catheter removal tool comprises a distal endtip configured to mechanically connect with a proximal end portion ofthe vascular access catheter.

In certain embodiments, a method of operating a medical device maycomprise operating an implanted vascular access port and a firstvascular access catheter connected to the vascular access port andextending into a blood vessel of a host such that a needle of thevascular access port penetrates through cutaneous tissue of the host tobecome exposed above the cutaneous tissue; establishing access to afluid passage of the vascular access port through a fluid passage accessopening of the needle, the fluid passage operable to introduce fluid tothe host and/or remove fluid from the host; introducing a guidewire intothe fluid passage of the vascular access port, through a lumen of thefirst vascular access catheter and into a lumen of a blood vessel of thehost; positioning a catheter removal tool on the guidewire; introducingthe catheter removal tool into the fluid passage of the vascular accessport; engaging the catheter removal tool with the first vascular accesscatheter; removing the first vascular access catheter from the hostthrough the fluid passage of the vascular access port with the catheterremoval tool; removing the catheter removal tool and the first vascularaccess catheter from the guidewire; positioning a second vascular accesscatheter on the guidewire; positioning a catheter insertion tool on theguidewire; introducing the second vascular access catheter and thecatheter insertion tool into the fluid passage of the vascular accessport; introducing the second vascular access catheter into the host suchthat the second vascular access catheter extends from the vascularaccess port to the lumen of the blood vessel of the host; removing thecatheter insertion tool from the fluid passage of the vascular accessport; and removing the guidewire from the lumen of the blood vessel ofthe host, through a lumen of the second vascular access catheter andfrom the fluid passage of the vascular access port.

In certain embodiments, a method of operating a medical device maycomprise disengaging a mechanical connection between the first vascularaccess catheter and the vascular access port after engaging the firstvascular access catheter with the catheter removal tool.

In certain embodiments, a method of operating a medical device maycomprise engaging a mechanical connection between the second vascularaccess catheter and the vascular access port after introducing thesecond vascular access catheter into the host.

FIGURES

Features and advantages of the claimed subject matter will be apparentfrom the following detailed description of some example embodimentsconsistent therewith, which description should be considered withreference to the accompanying drawings, wherein:

FIG. 1 illustrates a cross-sectional view of a vascular access port anda vascular access catheter implanted in a host, particularly beneathcutaneous (skin) tissue with a needle of the vascular access portextended and penetrating through the cutaneous tissue of the host tobecome exposed above the cutaneous tissue;

FIG. 2 is a close-up cross-sectional view of a section of the vascularaccess port and a section the vascular access catheter of FIG. 1 at theconnection thereof;

FIG. 3 is a close-up cross-sectional view of the connection formedbetween the vascular access port and the vascular access catheter ofFIG. 1;

FIG. 4 is a cross-sectional view of the vascular access port and thevascular access catheter of FIG. 1, with a guidewire inserted in thevascular access port and the vascular access catheter, and a catheterremoval tool inserted in the vascular access port; and

FIG. 5 is a close-up cross-sectional view of the distal end of thecatheter removal tool and a guidewire inserted in the lumen of thevascular access catheter of FIG. 4;

FIG. 6 is a close-up cross-sectional view of the distal end of acatheter insertion tool and a replacement vascular access catheterarranged on the guidewire in the vascular access port of FIG. 1;

FIG. 7 illustrates a cross-sectional view of the vascular access portand the vascular access catheter of FIG. 1 implanted in a host,particularly beneath cutaneous (skin) tissue with the needle of thevascular access port retracted into the vascular access port; and

FIG. 8 is a close-up cross-sectional view of the connection formedbetween the vascular access port and the vascular access catheteraccording to another embodiment of the disclosure.

DETAILED DESCRIPTION

It may be appreciated that the present disclosure is not limited in itsapplication to the details of construction and the arrangement ofcomponents set forth in the following description or illustrated in thedrawings. The invention(s) herein may be capable of other embodimentsand of being practiced or being carried out in various ways. Also, itmay be appreciated that the phraseology and terminology used herein isfor the purpose of description and should not be regarded as limiting assuch may be understood by one of skill in the art.

By way of a general overview, the present disclosure provides medicaldevices, systems and methods for removal and replacement of an implantedaccess catheter connected to an implanted access port. According to atleast one embodiment of the disclosure, a medical device may be providedwhich comprises an implantable vascular access port including a fluidpassage operable to introduce fluid to a host and/or remove fluid fromthe host, the fluid passage accessible through a fluid passage accessopening and at least a portion of the fluid passage defined by a needleconfigured to penetrate cutaneous tissue of the host, and an implantablevascular access catheter connectable with the vascular access port,wherein the vascular access catheter and the vascular access port areconnectable to each other within the vascular access port.

As disclosed herein, mechanical connections formed between thecomponents herein may include friction fit connections (which may alsobe referred to an interference or press fit) and positive mechanicalengagement connections. A friction fit connection may be understood as aconnection formed between the components which solely relies uponfriction to inhibit separation of the components, particularly by one ofthe components being pressed into the other component such that at leastone of the components is compressed (deformed) against the another. Onthe other hand, a positive mechanical engagement connection may beunderstood as a connection formed between the components which does notrely solely on friction to inhibit separation of the components andwhich includes a mechanical interlock to inhibit separation of thecomponents (e.g. overlapping surfaces).

Referring now to the figures, and particularly to FIG. 1, there is showna medical device 100 according to the present disclosure. Medical device100 may comprise an implantable (sub-cutaneous) vascular access port110. As shown, vascular access port 110 is implanted in a host 10 (e.g.patient, which may be undergoing medical treatment or diagnosis),particularly beneath the surface 30 of cutaneous (skin) tissue 20.

As shown, vascular access port 110 may comprise an outer housing 112including a base 114 supporting a cover 116, which may be made of asuitable (biocompatible) thermoplastic polymer composition, or metalsuch as titanium. Housing 112 may include an internal needle elevatormechanism 120 which may extend a pointed, closed tip, hollow needle 121(for better clarity, a pointed, removable, atraumatic, dilator tip 123as shown in FIG. 7 has been removed from shaft 122) out from the housing112 or retract the needle 121 into the housing 112 through an opening126 formed in the housing 112 (which may be provided in a self-sealingseptum or other self-closing membrane which provides a seal) on the topwall 116 a of the housing 112 closest to the surface 30 of cutaneous(skin) tissue 20.

As shown, needle elevator mechanism 120 comprises a movable needleplatform 130 which comprises a piston 132 to extend the needle 121 outof the housing 112 and to retract the needle 121 into the housing 112.The piston 132 of the needle platform 130 may move the needle 121relative to a surrounding support structure 140 which defines a chamber150 in which the needle platform 130 travels in opposing directions toextend and retract the needle 121. As shown, the needle elevatormechanism 120, and more particularly piston 132, may be configured toextend the needle 121 out of the housing 112 and to retract the needle121 into the housing 112 at an extension/retraction angle 0, relative tothe top wall 116 a of the housing 112 (and/or the surface 30 ofcutaneous (skin) tissue 20) in a range between 10 degrees and 90degrees. More particularly, the extension/retraction angle θ may be in arange of 45 degrees to 90 degrees.

Vascular access port 110 further includes an elongated L-shaped fluidflow passage 160, which may be formed at least in part by a tubular(cylindrical) bore which extends through piston 132 of needle platform130, and through the needle platform support structure 140. The fluidflow passage 160 is operable to introduce fluid to the host 10 from afluid source 70 and/or remove fluid from the host 10 to a fluidreceptacle 80.

The fluid flow passage 160 is accessible through fluid passage accessopening 125. Fluid passage access opening 125 may be covered with apointed, removable tip (shown at 123 in FIG. 7), which is at the end ofthe shaft 122 of needle 121, to keep the needle lumen 124 closed toingress of fluid(s) (particularly body fluid(s)), as well as to allowfor limited-volume flushing, when the vascular access port 110 is not inuse, particularly when the needle 121 is retracted. As shown, at least aportion of the fluid flow passage 160 is defined by the lumen 124 of theneedle 121, which may be particularly configured to penetrate thecutaneous tissue 20 of host 10. The needle 121 may be press-fit into thebore formed in the piston 132 other otherwise secured (e.g. mechanicallyor adhesively) within the bore.

Medical device 100 further comprises an implantable (indwelling)vascular access catheter 170 which is connectable with the vascularaccess port 110. The vascular access catheter 170 may particularlyextend from the vascular access port 110 into a lumen 50 of a bloodvessel 40 in the tissue 20 of the host 10. As shown by FIG. 1, thevascular access catheter 170 and the vascular access port 110 areconnectable to each other within the vascular access port 110. Thevascular access catheter 170 may be made of a suitable (biocompatible)thermoplastic polymer composition, such as a thermoplastic elastomer, orother suitable material.

As described in greater detail below, the vascular access catheter 170is insertable into the fluid flow passage 160 of the vascular accessport 110 through the fluid passage access opening 125 and removable fromthe fluid flow passage 160 of the vascular access port 110 through thefluid passage access opening 125. Furthermore, for the portion of thefluid flow passage 160 defined by the needle 121, as more particularlydefined by the lumen 124 of the needle 121, it should be understood thatthe vascular access catheter 170 is insertable into the lumen 124 of theneedle 121 through the fluid passage access opening 125 and removablefrom the lumen 124 of the needle 121 through the fluid passage accessopening 125.

Referring now to FIG. 2, there is shown a close-up view of a section ofthe vascular access port 110 and a section of the vascular accesscatheter 170. As mentioned above, and further explained below, thevascular access catheter 170 is particularly configured to be insertableand removable from the host 10 through the vascular access port 110. Inthe foregoing manner, should the vascular access catheter 170 becomepartially or fully occluded, it is possible to remove the vascularaccess catheter 170 without open surgery of the host 10 to remove thefirst (occluded) vascular access catheter 170 and replace the vascularaccess catheter 170 with a second (unoccluded) vascular access catheter170.

As shown by FIG. 2, the fluid flow passage 160 leads distally to acatheter egress opening 128 formed in the cover 116 of the housing 112.As explained in greater detail below, in order to form a mechanicalconnection between the vascular access catheter 170 and the vascularaccess port 110 within the vascular access port 110, the catheter egressopening 128 may have a smaller diameter D₂ than the diameter D₁ of thefluid flow passage 160, which results in a circular annular shoulder 118at the decrease in diameter.

As shown, the flexible tubular body 174 of the vascular access catheter170, shown as a cylindrical sidewall, has a diameter which is slightlyless than the smaller diameter D₂ of the catheter egress opening 128 (ascompared to the diameter D₁ of the fluid flow passage 160). As a result,the tubular body 174 of the vascular access catheter 170 may extend(pass) through the fluid flow passage 160 and the catheter egressopening 128.

However, while the tubular body 174 of the vascular access catheter 170may freely extend (pass) through the catheter egress opening 128, aproximal end portion 180 of the vascular access catheter 170 will notextend (pass) through catheter egress opening 128. More particularly,the proximal terminal end 176 of the vascular access catheter 170includes a circular annular flange 178 which has a diameter which isgreater than diameter D₂ of catheter egress opening 128 (and slightlyless than diameter D₁ of the of the fluid flow passage 160). It shouldbe understood that the term “proximal”, as well as the term “distal”with regards to the vascular access catheter 170 is used in reference tothe vascular access port 110 and, as such the distal terminal end of thevascular access catheter 170 should be understood to be inserted intothe lumen 50 of the blood vessel 40 of the host 10.

As such, as the tubular body 174 is inserted into fluid flow passage 160through fluid passage access opening 125, the vascular access catheter170 may freely extend (pass) through the fluid flow passage 160 andcatheter egress opening 128 of the vascular access port 110 until theflange 178 of the vascular access catheter 170 makes contact withshoulder 118 of the vascular access port 110, provided by sidewall 116 bof cover 116 of housing 112, which will prevent the vascular accesscatheter 170 from being removed from the vascular access port 110through sidewall 116 b of cover 116 by virtue of the overlap createdbetween the flange 178 of the vascular access catheter 170 and theshoulder 118 of the vascular access port 110 provided by sidewall 116 bof cover 116.

The overlap created between the flange 178 of the vascular accesscatheter 170 and the shoulder 118 of the vascular access port 110provides a mechanical (overlapping) connection, which may also bereferred to as a mechanical interference, within the inside of thevascular access port 110 between the vascular access catheter 170 andthe vascular access port 110. As shown, the connection is formed with aportion of the vascular access port 110, here shoulder 118 provided byhousing 112, which defines at least a portion of the catheter egressopening 128. More particularly, the overlap created provides a positivemechanical engagement connection between the vascular access catheter170 and the vascular access port 110.

Even more particularly, the overlap created provides a one-way positivemechanical engagement connection between the vascular access catheter170 and the vascular access port 110. In other words, while the positivemechanical engagement prevents the vascular access catheter 170 frombeing pulled from the vascular access port 110 through the catheteregress opening 128 of the vascular access port 110, the positivemechanical engagement does not prevent the vascular access catheter 170from being pulled from the vascular access port 110 through the fluidpassage access opening 125 to replace the vascular access catheter 170.

To prevent body fluids (e.g. blood) of the host 10 which surround thevascular access catheter 170 from ingress into the vascular access port110, the vascular access port 110 may include a seal member 162 (e.g.O-ring) which seals against the tubular body 174 of the vascular accesscatheter 170. Furthermore, vascular access port 110 may also include oneof more seal members 164 (e.g. O-rings) to prevent body fluids of thehost 10 located in the fluid flow passage 160 of the vascular accessport 110 from ingress between needle platform 130 and the surroundingsupport structure 140, as well as chamber 150, particularly when thepiston 132 is not activated.

Referring now to FIG. 3, in order to inhibit the vascular accesscatheter 170 from moving proximally into the fluid flow passage 160(e.g. by fluid pressure of the host 10), particularly after the flange178 of the vascular access catheter 170 makes contact with shoulder 118of the vascular access port 110, the proximal end portion 180 of thevascular access catheter 170 may include at least one resilient(deformable) retention element 182 to retain a seated position of thevascular access catheter 170 within the vascular access port 110.

As shown, the proximal end portion 180 of the vascular access catheter170 includes a plurality of retention elements 182 which are arranged asa series of circular annular deformable retention barbs, which may alsobe referred to as fins, which each extend continuously around theexternal perimeter of the tubular body 174 and press against the wall117 of catheter egress opening 128 formed by sidewall 116 b of the cover116 to provide a friction fit connection. More particularly, thefriction fit connection comprises a press-fit connection, formed by theretention elements 182, and more particularly the barbs, deformingagainst the wall 117 of the catheter egress opening 128 when locatedtherein. The retention barbs may comprise thin ribs formed perpendicularto the longitudinal axis of the tubular body 174. As shown for clarity,only a portion of the retention elements 182 are engaged. Retentionelements 182, as well as flange 178 of the vascular access catheter 170may be formed as a single (monolithic) structure with a remainder of thetubular body 174 of the vascular access catheter 170 or may be made ofseparate components attached to the tubular body 174, in which case theretention elements 182 and/or flange 178 may be made of a differentmaterial from the tubular body 174, such as rigid plastic or metal. Theretention elements 182 and/or flange could also be formed as an attachedring to the tubular body 174, which may be threaded or textured.

In the foregoing manner, unlike the positive mechanical connectiondiscussed above, the friction fit connection inhibits the vascularaccess catheter 170 from being pulled from the vascular access port 110through the fluid passage access opening 125 until consciouslydisengaged.

Referring now to FIG. 4, in order to remove and replace vascular accesscatheter 170 after the vascular access port 110 and the vascular accesscatheter 170 have been implanted, with the vascular access catheter 170extending into a blood vessel of the host the implanted vascular accessport 110 may be operated such that the needle 121 of the vascular accessport 110 penetrates through cutaneous tissue 20 of the host 10 to becomeexposed above the cutaneous tissue 20.

Thereafter, access to the fluid passage 160 of the vascular access port110 may be established through fluid passage access opening 125 of theneedle 121, particularly by removing removable tip 123 (see FIG. 7) fromthe shaft 122 of needle 121. As set forth above, the fluid flow passage160 may be operable to introduce fluid to a host 10 and/or remove fluidfrom the host 10. Thereafter, a guidewire 200 may be extended into thefluid flow passage 160 as may be taught by the Seldinger technique.

A guidewire 200 may then be extended into the fluid flow passage 160 ofthe vascular access port 110, through lumen 172 of the vascular accesscatheter 170, such that they are arranged coxially, and into a lumen 50of a blood vessel 40 of the host 10, with the distal end 202 of theguidewire 200 being located within the lumen 50 of the blood vessel 40of host 10. Placement of the guidewire 200 in the lumen 50 of the bloodvessel 40 of host 10 may be similar to that taught by the Seldingertechnique.

Referring now to FIGS. 4 and 5, after the guidewire 200 is properlypositioned, a catheter removal tool 220 may be positioned on theguidewire 200 and used to remove vascular access catheter 170 byintroducing the catheter removal tool 220 into the fluid flow passage160 of the vascular access catheter 170.

As explained in greater detail below, the catheter removal tool 220 isconfigured to operate with the guidewire 200 and configured to removethe vascular access catheter 170 from the vascular access port 110through the fluid flow passage 160 and the fluid passage access opening125 of the vascular access port 110, as well as configured to disengagethe mechanical connection between the vascular access catheter 170 andthe vascular access port 110, particularly by applying a pulling forceto the vascular access catheter 170. In order to achieve such, thecatheter removal tool 220 comprises a distal end tip 230 configured tomechanically connect with the proximal end portion 180 of the vascularaccess catheter 170.

As shown, catheter removal tool 220 comprises a flexible tubular body222 including a lumen 224. At the distal end portion of the catheterremoval tool 220 is located a distal end tip 230 which includes a tipbody 232 having a centrally disposed lumen 234 with a distal end opening236 through which the guidewire 200 extends distally.

Tip body 232 further comprises at least one resilient tip bodyengagement element 238. Tip body 232 is configured to enter the lumen172 of the vascular access catheter 170 defined by tubular body 174, andthe resilient tip body engagement element 238 is configured to engagewith the tubular body 174 of the vascular access catheter 170. As shown,the tip body 232 includes a plurality of engagement elements 238 whichare arranged as a series of circular annular engagement barbs, whicheach extend continuously around the perimeter of the tip body 232 andpress against the tubular body 174 of the vascular access catheter 170to provide a friction fit or other mechanical connection. As shown, thebarbs may be formed perpendicular to the longitudinal axis of the tipbody 232.

By applying a pushing force to the tubular body 222 of the catheterremoval tool 220 adjacent to the entrance of needle 121, the tip body232 may be forced to enter the lumen 172 of the vascular access catheter170, and the plurality of engagement elements 238 engage tubular body174 of the vascular access catheter 170.

Thereafter, by applying a pulling force to the tubular body 222 of thecatheter removal tool 220 adjacent to the entrance of needle 121, theretention elements 182 of the vascular access catheter 170 may bedisengaged from engagement with the wall 117 of catheter egress opening128 formed by sidewall 116 b of the cover 116 to disengage themechanical connection there between, particularly as the separationforce required to disengage the catheter removal tool 220 from thevascular access catheter 170 is configured to be greater than theseparation force required to disengage the vascular access catheter 170from the cover 116 of the vascular access port 110.

Thereafter, the (occluded) vascular access catheter 170 may be removedfrom the host 10 through the fluid flow passage 160 of the vascularaccess port 110 with the catheter removal tool 220, particularly bysliding it axially over and along the guidewire 220, which is heldstationary.

After the catheter removal tool 220 and the occluded vascular accesscatheter 170 are removed from the host 10 by being slid axially alongthe guidewire 220, the catheter removal tool 220 and the occludedvascular access catheter 170 are removed from the guidewire 220.

Thereafter, a second (unoccluded) vascular access catheter 170 may bepositioned on the guidewire 220 with the guidewire 220 within lumen 172and slid axially along the length of the guidewire 220 to be insertedinto the fluid flow passage 160 of the vascular access port 110 throughthe fluid passage access opening 125. The second vascular accesscatheter 170 may then follow the guidewire 220 through the tissue 20 ofthe host 10 and into lumen 50 of blood vessel 40.

Referring now to FIG. 6, in order to properly seat (position) theplurality of retention elements 182 of the vascular access catheter 170against the wall 117 of catheter egress opening 128 formed by sidewall116 b of the cover 116 of the vascular access port 110, a catheterinsertion tool 250 may be positioned on the guidewire 200 proximal tothe vascular access catheter 170.

As explained in greater detail below, the catheter insertion tool 250 isconfigured to operate with the guidewire 200 and configured to insertthe vascular access catheter 170 into the vascular access port 110through the fluid passage access opening 125 and the fluid flow passage160 of the vascular access port 110, as well as configured to engage amechanical (friction fit) connection between the vascular accesscatheter 170 and the vascular access port 110, particularly by applyinga pushing force to the vascular access catheter 170.

As shown, the catheter insertion tool 250 may include flexible tubularbody 252 including a lumen 254. At the distal end portion of thecatheter insertion tool 250 is located a distal end tip 260 whichincludes a tip body 262 having a centrally disposed lumen 264 with adistal end opening 266 through which the guidewire 200 extends distally.

Tip body 262 further comprises a circular annular flange 268 which has adiameter which is substantially the same as the diameter of flange 178of the vascular access catheter 170. In this manner, when a pushingforce is applied to the tubular body 252 of the catheter insertion tool250, the circular flange 268 of the tip body 262 pushes against theflange 178 of the vascular access catheter 170 such that the retentionelements 182 of the vascular access catheter 170 are properly seated tothe cover 116 of the vascular access port 110.

After the vascular access catheter 170 and the catheter insertion tool250 are introduced into the fluid flow passage 160 of the vascularaccess port 110, a pushing and/or rotational force may be applied to thetubular body 252 of the catheter insertion tool 250 adjacent to theentrance of needle 121, which will result in flange 268 of the tip body262 pushing on flange 178 of the vascular access catheter 170. As aresult, the proximal end portion 180 of the vascular access catheter 170may be forced into catheter egress opening 128, such that the pluralityof retention elements 182 of the vascular access catheter 170 deformagainst the wall 117 of catheter egress opening 128 formed by sidewall116 b of the cover 116 of the vascular access port 110 to engage themechanical (friction fit) connection there between. Thereafter, thecatheter insertion tool 250 may be removed from the fluid flow passage160 of the vascular access port 110, and the guidewire 220 may beremoved from the lumen 50 of the blood vessel 40 of the host 10, throughlumen 172 of the first vascular access catheter 170 and from the fluidflow passage 160 of the vascular access port 110. After such have beenremoved, the needle tip 123 may be replaced and the vascular access port110 may be operated such that the needle 121 of the vascular access port110 retracts into or below the cutaneous tissue 20 of the host 10.

With regards to extension and retraction of needle 121, as set forthabove, FIG. 1 shows movable needle platform 130, and more particularlypiston 132, in an extended position in which needle 121 is extended outof the housing 110. In contrast, referring now to FIG. 7, there is shownmovable needle platform 130, and more particularly piston 132, in aretracted position in which needle 121 is retracted into the housing110, and is fully contained within the housing 110.

Movable needle platform 130, as well as piston 132 and needle 121 may bemade to extend and retract with use of magnetic forces, in which case asat least a portion of piston 132 comprises a magnetic material,particularly ferromagnetic material, such as iron, nickel and/or cobalt.

As shown in FIG. 7, movable needle platform 130 is made operable by ahand-held actuator 300 which, during use, may overlie the surface 30 ofcutaneous (skin) tissue 20 of host 10. More particularly, actuator 300may include a body 310 which includes a magnet, particularly anelectromagnet 314, which may be arranged to operate with an electricalpower source, particularly providing direct current to the electromagnet314.

During use, actuator 300 may be placed over the surface 30 of cutaneous(skin) tissue 20 of host 10, with contact elements 312 in contact withthe skin surface 30. Contact elements 312 may be used to space the body310 and/or electromagnet 314 a short distance from the skin surface,e.g. 1-2 mm.

As shown, the electromagnet 314 comprises at least one electro-magnetic(wire) coil 316, and may comprise a magnetic core 218. Magnetic core 318may be understood to be a piece of ferromagnetic material (e.g. iron) inthe center of the coil 316 which increases the magnetic field. Theelectric current passed through the coil magnetizes the iron, and thefield of the magnetized material adds to the magnetic field produced bythe coil 316.

Also as shown, only a portion of the interior of the coil 316 isoccupied by the core 318, with the remainder of the unoccupied spacecreating a recess 320. As explained in greater detail below, recess 320is to receive needle 121 therein during operation of the actuator 300.

When an electric current of a first polarity is provided toelectro-magnet 314, and more particularly electro-magnetic coil 316,coil 316 may emit an electro-magnetic field arranged with a firstpolarity which attracts the movable needle platform 130, and moreparticularly the piston 132, to the electro-magnet 314, in which casethe movable needle platform 130, and more particularly the piston 132,within housing 112 will be pulled towards the electro-magnet 314 by theforce of the electromagnetic field and travel upwards (outwards relativeto the host 10) in piston chamber 150.

As the movable needle platform 130/piston 132 travel upwards in pistonchamber 150, needle 121 correspondingly extends and passes outwardlythrough opening 126, at which time the needle 121 continues to traveloutwardly and pierces through cutaneous (skin) tissue 20, and moreparticularly surface 30. The exposed portion of the needle 121 may thanenter recess 320 of actuator 300. After the needle 121 has been pulledthrough cutaneous (skin) tissue 20, actuator 230 may be removed and theneedle 121 may be accessed.

As shown, the tip 123 of the needle 121 is designed to operate as adilator once the distal (terminal) pointed end of the tip 121 (while maybe referred to as a pencil tip) has penetrated through the cutaneous(skin) tissue 20. With the configuration as shown, the tip 123 of theneedle dilates the tissue 20 rather than cutting through the tissue 20to minimize injury.

Alternatively, when it becomes desirable to retract the needle 121 backinto housing 112, after the tip 123 has been placed on needle 121, anelectric current of a second polarity opposite the first polarity (i.e.reverse polarity) is provided to electromagnet 310, and moreparticularly the electro-magnetic coil 316. Coil 316 may then emit anelectro-magnetic field arranged with a second polarity which repels themovable needle platform 130, and more particularly the piston 132, fromthe electro-magnet 314, in which case the movable needle platform 130,and more particularly the piston 132, within housing 112 will be pushedaway from the electromagnet 314 by the force of the electromagneticfield and travel downwards (inwards relative to the host 10) into thepiston chamber 150.

As the movable needle platform 130/piston 132 travel downwards in pistonchamber 150, needle 121 correspondingly retracts and withdraws intocutaneous (skin) tissue 20, and more particularly surface 30 andcontinues to retract through opening 126 and back into chamber 150.After the needle 121 has retracted into housing 112, actuator 300 may beremoved.

In another embodiment of the present disclosure, as shown in FIG. 8, thehousing 112 may further include a connectable/disconnectable catheterretention member 190 which is detachably connectable to the sidewall 116b of cover 116. As shown, the catheter retention member 190 may comprisea screw thread 192 which threadably engages with a screw thread 194provided on the sidewall 116 of the cover 116 to connect the catheterretention member 190 to the sidewall 116 b of the cover 116 when thecatheter retention member 190 is rotated in a first direction (e.g.clockwise) relative to the cover 116. Alternatively, when the catheterretention member 190 is rotated on a second direction opposite of thefirst direction (e.g. counterclockwise), screw thread 192 threadablydisengages from screw thread crew thread 194 provided on the sidewall116 of the cover 116 to disconnect the catheter retention member 190from the sidewall 116 b of the cover 116. In order to rotate thecatheter retention member 190 relative to the housing 112, the catheterretention member 190 may be provided in the form of aconnectable/disconnectable stem which extends outward from sidewall 116b of the cover 116. Rotation of the catheter retention member 190 may bebetter facilitated by extending the catheter retention member 190 fromsidewall 116 b of the cover 116. To facilitate grasping by hand or atool such as an open ended wrench, in which the catheter retentionmember 190 may comprises a hexagonal portion to be gripped by thewrench.

As shown, the catheter egress opening 128 extends through the catheterretention member 190 such that the vascular access catheter 170 may passthrough the catheter retention member 190. Similar to the firstembodiment, as the tubular body 174 is inserted into fluid flow passage160 through fluid passage access opening 125, the vascular accesscatheter 170 may freely extend (pass) through the fluid flow passage 160and catheter egress opening 128 of the vascular access port 110 untilthe flange 178 of the vascular access catheter 170 makes contact withshoulder 118 of the vascular access port 110, provided by the catheterretention member 190 of housing 112), which will prevent the vascularaccess catheter 170 from being removed from the vascular access port 110through sidewall 116 b of cover 116 by virtue of the overlap createdbetween the flange 178 of the vascular access catheter 170 and theshoulder 118 of the vascular access port 110 provided by catheterretention member 190.

However, in contrast to the first embodiment, the embodiment of FIG. 8permits the vascular access catheter 170 to be separated from thevascular access port 110 without extending needle 121 out from thehousing 112 and removing removable tip 123 to gain access to flowpassage 160. Thus, if a need arises to replace the vascular access port110 without replacing the vascular access catheter 170, such may beperformed with a minimally invasive procedure where the cutaneous tissue(skin) 20 of the host 10 may be cut through from the surface 30 toaccess catheter retention member 190. Catheter retention member 190 maythen be disconnected from the implanted vascular access port 110, alongwith implanted vascular access catheter 170. The implanted vascularaccess port 110 may then be replaced with a new vascular access port 110without necessarily replacing the vascular access catheter 170, whichmay become desirable, for example, should the vascular access port 110have operational difficulties or otherwise need to be replaced.

While a preferred embodiment of the present invention(s) has beendescribed, it should be understood that various changes, adaptations andmodifications can be made therein without departing from the spirit ofthe invention(s) and the scope of the appended claims. The scope of theinvention(s) should, therefore, be determined not with reference to theabove description, but instead should be determined with reference tothe appended claims along with their full scope of equivalents.Furthermore, it should be understood that the appended claims do notnecessarily comprise the broadest scope of the invention(s) which theapplicant is entitled to claim, or the only manner(s) in which theinvention(s) may be claimed, or that all recited features are necessary.

What is claimed is:
 1. A medical device comprising: an implantableaccess port including a fluid passage operable to introduce fluid to ahost and/or remove fluid from the host, the fluid passage accessiblethrough a fluid passage access opening; a needle configured to penetratethe host, wherein at least a portion of the fluid passage is defined bythe needle; an implantable catheter connectable with the access port,the catheter having a proximal end and a distal end; wherein thecatheter is connectable with the access port by a mechanical connection;wherein the portion of the fluid passage defined by the needle isdefined by a lumen of the needle; wherein the catheter is insertableinto the fluid passage of the access port, including the lumen of theneedle, through the fluid passage access opening; and wherein thecatheter is advanceable through the fluid passage such that the distalend of the catheter extends from the access port; a catheter insertiontool configured to insert the catheter into the access port through thefluid passage access opening and the fluid passage of the access port;and wherein the catheter insertion tool is configured to engage themechanical connection between the catheter and the access port.
 2. Thedevice of claim 1 wherein: the catheter is removable from the accessport through the fluid passage and the fluid passage access opening.3-4. (canceled)
 5. The device of claim 1 wherein: the mechanicalconnection comprises at least one of a friction fit connection and apositive mechanical engagement connection.
 6. The device of claim 5wherein: the positive mechanical engagement connection comprises anoverlapping connection formed by a proximal end portion of the catheterand a portion of the access port.
 7. The device of claim 6 wherein: theoverlapping connection is formed by a flange of the catheter overlappingwith a shoulder of the access port.
 8. The device of claim 5 wherein:the friction fit connection comprises a press-fit connection formed by aproximal end portion of the catheter and a portion of the access port.9. The device of claim 8 wherein: the press-fit connection is formed byat least one deformable retention element of the catheter. 10-11.(canceled)
 12. The device of claim 1 wherein: the access port includes ahousing; and the mechanical connection is formed with the housing and/orwithin the access port. 13-17. (canceled)
 18. The device of claim 1wherein: the catheter is connectable with the access port within thefluid passage of the access port. 19-20. (canceled)
 21. The device ofclaim 1 wherein: the catheter insertion tool is configured to operatewith a guidewire.
 22. The device of claim 1 further comprising: acatheter removal tool configured to remove the catheter from the accessport through the fluid passage and the fluid passage access opening ofthe access port.
 23. The device of claim 22 wherein: the catheterremoval tool is further configured to disengage the mechanicalconnection between the catheter and the access port.
 24. The device ofclaim 23 wherein: the catheter removal tool is configured to disengagethe mechanical connection between the catheter and the access port bypulling the catheter out of engagement with the access port in apresence of a pulling force applied to the catheter removal tool. 25.The device of claim 22 wherein: the catheter removal tool is configuredto operate with a guidewire. 26-28. (canceled)
 29. The device of claim22 wherein: the catheter removal tool is connectable with the catheterby a mechanical connection with the catheter.
 30. The device of claim 29wherein: the mechanical connection comprises at least one of a frictionfit connection and a positive mechanical engagement connection.
 31. Thedevice of claim 29 wherein: the catheter removal tool comprises a distalend portion; the catheter comprises a proximal end portion; and thecatheter removal tool is connectable with the catheter by the distal endportion of the catheter removal tool forming the mechanical connectionwith the proximal end portion of the catheter.
 32. The device of claim31 wherein: the distal end portion of the catheter comprises a tip body;the tip body comprises at least one tip body engagement element; the atleast one tip body engagement element forms the mechanical connectionwith the proximal end portion of the catheter.
 33. The device of claim32 wherein: the at least one tip body engagement element comprises anengagement barb.
 34. The device of claim 32 wherein: the cathetercomprises a catheter tubular body and a catheter lumen; and the at leastone tip body engagement element forms the mechanical connection with thecatheter tubular body.
 35. The device of claim 34 wherein: the at leastone tip body engagement element forms the mechanical connection with thecatheter tubular body within the catheter lumen.
 36. The device of claim1 wherein: the catheter insertion tool is configured to engage themechanical connection of the catheter and the access port by pushing thecatheter into engagement with the access port in a presence of a pushingforce applied to the catheter insertion tool.
 37. The device of claim 36wherein: the catheter insertion tool comprises a distal end portion. thedistal end portion comprises a tip body; the tip body comprises tip bodyannular flange; the catheter comprises a catheter annular flange; andthe tip body annular flange is configured to push against the catheterannular flange in the presence of the pushing force.